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Endovascular Repair

ChEVAS for Abdominal Aortic Aneurysm (ChEVAS One Trial)

N/A
Waitlist Available
Research Sponsored by Endologix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Abdominal aortic aneurysm (AAA) with specific size criteria
Be older than 18 years old
Must not have
Unsuitable vascular anatomy that may interfere with device introduction or deployment
Requirement of home oxygen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year
Awards & highlights

Summary

This trial will test a new endovascular repair system for complex abdominal aortic aneurysms. Subjects will be enrolled at multiple sites, and the trial will assess the safety and effectiveness of the device.

Who is the study for?
This trial is for adults over 18 with abdominal aortic aneurysms meeting specific size criteria and without significant vessel angulation. Candidates must consent to follow-up visits, not be in other studies within the last 30 days, have no allergies to materials used, or conditions like Marfan Syndrome that could affect results.
What is being tested?
The study tests the ChEVAS System for repairing complex abdominal aortic aneurysms. It's prospective and non-randomized, meaning all eligible participants at each center get the new treatment without being compared to another group receiving a different treatment.
What are the potential side effects?
While not explicitly listed here, potential side effects may include complications related to endovascular procedures such as blood vessel damage, infection risk at the incision site, allergic reactions to materials used in the system or contrast media during imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have an abdominal aortic aneurysm of a specific size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood vessels may not allow for safe medical device use.
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I need oxygen at home.
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I have a stent in a major artery that could affect new treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Safety and Effectiveness Indicators at One-Year Post-Index Procedure
Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure

Trial Design

1Treatment groups
Experimental Treatment
Group I: ChEVAS SystemExperimental Treatment1 Intervention
The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms.

Find a Location

Who is running the clinical trial?

EndologixLead Sponsor
22 Previous Clinical Trials
3,959 Total Patients Enrolled

Media Library

Chimney Endovascular Aortic Sealing (ChEVAS) System (Endovascular Repair) Clinical Trial Eligibility Overview. Trial Name: NCT04252573 — N/A
Abdominal Aortic Aneurysm Research Study Groups: ChEVAS System
Abdominal Aortic Aneurysm Clinical Trial 2023: Chimney Endovascular Aortic Sealing (ChEVAS) System Highlights & Side Effects. Trial Name: NCT04252573 — N/A
Chimney Endovascular Aortic Sealing (ChEVAS) System (Endovascular Repair) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04252573 — N/A
~3 spots leftby Sep 2025
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